Update on FDA and Tobacco Issues

The FDA’s Center for Tobacco Products is now in its fourth year of regulating tobacco products. New regulations on other tobacco products should be released soon; graphic-cigarette warning litigation continues; the FDA is seeking to survey citizens on graphic warnings; and a final agency report on menthol is being drafted.

OTP Regulations

In December, the FDA released a Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products under the terms of the Family Smoking Prevention and Tobacco Control Act. The FDA currently regulates cigarettes, roll-your-own tobacco and smokeless tobacco products.

While the other tobacco products that the FDA intends to regulate will not be known until the proposed rule is released, the FDA issued a letter in April 2011 that states the agency plans “to ensure that appropriate regulatory mechanisms govern all ‘tobacco products ‘under the act and all other products made or derived from tobacco.”

The letter from the FDA states that additional tobacco product categories would be subject to product registration, product listing, ingredient listing, good manufacturing practice requirements, product user fees, adulteration and misbranding provisions, and premarket review requirements for new tobacco products and modified-risk tobacco products.

The Regulatory Agenda notice states that the proposed tobacco regulations should be issued no later than April 2013. When the regulations are released, the public will have 60 days to submit comments. The FDA will then review the comments and issue a final regulatory rule.

Graphic Warning Labels

Two industry lawsuits challenging the FDA’s graphic cigarette warning labels have proceeded to the appeals stage, with the Sixth Circuit Court of Appeals upholding the constitutionality of the warning labels and the District of Columbia Circuit Court of Appeals striking down the warnings as unconstitutional.

The industry plaintiffs have petitioned the U.S. Supreme Court to accept the Sixth Circuit decision for review, while the FDA must decide whether to petition the Supreme Court to review the District of Columbia Circuit ruling. With these lawsuits pending, the FDA has issued a statement that the graphic warning label requirements will not be implemented.

Graphic Label Survey

On Dec. 5, 2012, the FDA filed a request with the Office of Management and Budget (OMB) to approve restarting an Internet survey of individuals aged 13 and older to evaluate the effectiveness of graphic cigarette health warnings on cigarette packages.

The National Association of Tobacco Outlets (NATO) has filed a set of comments with the OMB asking the agency to decline the FDA’s request. NATO’s comments state that with two federal lawsuit spending and the FDA not implementing the graphic health warnings due to the ongoing litigation, the purpose of restarting the online survey of the public is contradictory and unnecessary. In addition, NATO’s comments state that the FDA’s request brings into question the propriety of spending federal funds to survey citizens when the survey data maybe unusable if the Supreme Court strikes down the graphic warnings.

Menthol Review

On March 23, 2011, the FDA’s Tobacco Product Scientific Advisory Committee issued a report on menthol in cigarettes. The FDA reviewed the report, evaluated all available science related to the impact of menthol in cigarettes, and then drafted and submitted the agency’s own report to external scientists for peer review. The FDA is now revising its report based on feedback from these scientists and will make its final report available for public comment.

Then, based on these reports, the scientific feedback and public comments, the FDA will consider possible regulatory actions regarding menthol in cigarettes. However, under the act, the FDA is not required to take any regulatory action on menthol in cigarettes.